Phase 1 Study of Dual-Target BCMA-CD19 CAR-T Cell Therapy for Adults with Relapsed or Refractory Multiple Myeloma and Extramedullary Infiltration

What this Trial Is About

Researchers are investigating a dual-targeting BCMA-CD19 CAR-T cell therapy for patients with relapsed or refractory multiple myeloma who have extramedullary infiltration. This phase 1, multicenter, open-label, single-arm trial aims to evaluate the safety of this dual-target CAR-T treatment. The study will primarily assess dose-limiting toxicities and adverse events occurring within one month after treatment to better understand the therapys safety profile. Participants will receive a lymphodepletion chemotherapy regimen consisting of fludarabine and cyclophosphamide for about 3 to 5 days before the CAR-T cell infusion. The dual-target BCMA-CD19 CAR-T cells will be infused 48 hours after completing chemotherapy. This single treatment approach focuses on targeting two specific markers on cancer cells to address extramedullary lesions in multiple myeloma. During the study, participants will be closely monitored for safety and treatment effects, including the type and frequency of toxicities within the first month. Researchers will also measure outcomes such as remission rates over 90 days and survival outcomes up to two years. Safety evaluations, organ function tests, and assessments of disease markers will be conducted regularly to understand the treatments impact over time. The trial will enroll up to 18 participants aged 18 to 75 years and includes follow-up for up to two years to assess long-term outcomes.

Dual-target BCMA-CD19 CAR-T Cell Therapy for RR/MM With Extramedullary Infiltration